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FDA First Amendment Litigation: Will Amarin Case Break The Log Jam?

 
• By Brenda Sandburg

Courts have issued mixed rulings in cases challenging FDA restrictions on drug promotion, but with oral arguments set for July 7, Amarin’s suit could provide a definitive answer on what companies can tell physicians.

FDA has been hit with numerous suits claiming its regulations on drug promotion violate the First Amendment. While courts have issued mixed rulings there has been no definitive decision on what companies can tell health care providers about the unapproved uses of their drugs. But Amarin Pharmaceuticals Inc.’s case could change that.

The company filed suit against the agency in May seeking a declaration that the agency’s regulations on off-label drug promotion are unconstitutional and a preliminary injunction preventing FDA from taking...

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More from North America

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